BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7990224 · Received October 22, 2018

    Report

    Report Number
    1823260-2018-03768
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 22, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702128101
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE RESULT FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT FROM THE METER WAS 3.5 INR. THE RESULT FROM A LABORATORY USING DADE INNOVIN REAGENT WAS 2.6 INR. THE SAMPLE WAS DRAWN WITHIN HALF AN HOUR FROM THE METER TEST. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT HAD NO HEMATOCRIT CONCERNS, TOOK NO BLOOD THINNERS OTHER THAN COUMADIN, AND HAD NO ANTIPHOSPHOLIPID ANTIBODIES. THE THERAPEUTIC RANGE WAS 2.0 TO 3.0 INR. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. THE RETURNED TEST STRIPS WERE TESTED WITH COMPARABLE RETENTION TEST STRIPS ON INTERNAL REFERENCE METERS. ADDITIONAL MEASUREMENTS WERE PERFORMED WITH MASTERLOT #28632180 (RECALIBRATED LOT TO RTF/09). TESTING RESULTS: QC 1: 2.3 INR; QC 2: 2.3 INR; QC 3: 2.3 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION MASTER LOT STRIP LOT - QC LOT. (1.9 - 2.9 INR). ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. RETENTION TEST STRIPS (LOT 244031-14) WERE TESTED IN COMPARISON TO MASTERLOT #28632180 (RECALIBRATED LOT TO RTF/09). FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL COMPLIES WITH SPECIFICATION. NO INFORMATION WAS PROVIDED IN THE COMPLAINT CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833522 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403114 00365702128101

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR